Microendoscopic EI Sensing for Real-time Intraoperative Surgical Margin Assessment (RARP EI)

Microendoscopic Electrical Impedance Sensing for Real-time Intraoperative Surgical Margin Assessment

This research will study a custom device developed to detect if any prostate cancer tissue is left behind when the prostate is removed. This device is called an Electrical Impedance Imaging (EII) probe.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Device: custom device to demonstrate a significant difference in electrical impedance signatures

Detailed Description

Two hundred men will be recruited to participate in this trial. Consent will be obtained from all participating men prior to surgery.

The trial will consist of recording EII data from:

1. In vivo pelvic floor and peri-prostatic tissues remaining after the prostate has been resected
2. Resected ex vivo prostate following extraction from the abdomen (in the OR)
3. Resected ex vivo prostate when transferred to Pathology, post-RARP

The study team will also track post-surgical complications due to the study's technology (e.g., infection) and additional time required to deploy the study technology used to assess feasibility of clinical integration of the EII device. Post-RARP pathological assessment of margin tissues will be used to train and evaluate the study's classification schemes for identifying Positive Surgical Margin (PSMs).

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Ryan J Halter, PhD; Phone Number: (603) 646-0773; Email: Ryan.J.Halter@dartmouth.edu
• Study Contact Backup: Name: Kathy J Phipps, BA; Phone Number: 603 646-5793; Email: kathy.j.phipps@dartmouth.edu

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Recruiting
      • Dartmouth-Hitchcock Medical Center
      • Contact: Lawrence M Dagrosa, MD; Phone Number: 603-650-8123; Email: Lawrence.M.Dagrosa@hitchcock.org
      • Sub-Investigator: Einar Sverrisson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Men with a diagnosis of prostate cancer who require surgery.

Description

Inclusion Criteria:

1. Clinical diagnosis of prostate cancer requiring RARP.
2. Ability to understand and the willingness to sign a written informed consent document.
3. Age ≥ 18 years old

Exclusion Criteria:

1. Adults with implanted electrical devices such as pacemakers
2. Prisoners
3. Adults with impaired decision-making capacity
4. Any condition for which, in the opinion of the investigator, contraindicates study participation.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrical impedance difference between positive and negative surgical margins	Outcome measures will include how significantly different electrical impedance signatures are between impedance recordings of positive and negative surgical margins as acquired during prostate surgery.	2023-2025

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of EI sensing in vivo electrical sensing	Secondary outcome measures will include number of study-related adverse events documented.	2023-2025
Efficacy of EI sensing in vivo electrical sensing	Tertiary outcome measures will include classification accuracy of EI-based surgical margin assessment	2023-2025

Collaborators and Investigators

• Sponsor: Ryan J. Halter
• Collaborators: Dartmouth College
• Investigators: Principal Investigator: Ryan J Halter, PhD, Dartmouth-Hitchcock, Manchester

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 31, 2023
• First Submitted That Met QC Criteria: September 8, 2023
• First Posted (Actual): September 15, 2023

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 23, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: STUDY02001660

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No